WO2014116482A1 - Antiseptic applicator - Google Patents
Antiseptic applicator Download PDFInfo
- Publication number
- WO2014116482A1 WO2014116482A1 PCT/US2014/011650 US2014011650W WO2014116482A1 WO 2014116482 A1 WO2014116482 A1 WO 2014116482A1 US 2014011650 W US2014011650 W US 2014011650W WO 2014116482 A1 WO2014116482 A1 WO 2014116482A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- applicator
- dye
- foam
- foam layer
- antiseptic solution
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M35/00—Devices for applying media, e.g. remedies, on the human body
- A61M35/003—Portable hand-held applicators having means for dispensing or spreading integral media
- A61M35/006—Portable hand-held applicators having means for dispensing or spreading integral media using sponges, foams, absorbent pads or swabs as spreading means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/80—Implements for cleaning or washing the skin of surgeons or patients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M35/00—Devices for applying media, e.g. remedies, on the human body
- A61M35/003—Portable hand-held applicators having means for dispensing or spreading integral media
Definitions
- the present disclosure relates to an antiseptic applicator and method of use thereof, and more particularly, to an antiseptic applicator that provides a stable tinted antiseptic solution.
- Antiseptic applicators for the preparation of a patient prior to surgery are known and common in the prior art.
- Related art applicators rely on various means of actuation to release a self-contained reservoir of antimicrobial solution for sterilization of the patient's skin.
- a number of applicators are designed with a puncturing means.
- These applicators typically include a head with a spike, for example, and a sealed container or cartridge. A push or screw motion is employed to axially translate the head toward the sealed container so that the spike may pierce the sealed container and effectuate the release of the solution contained therein.
- Some examples of applicators using a puncturing means include U.S. Pat. Nos. 4,415,288; 4,498,796; 5,769,552; 6,488,665; and 7,201 ,525; and U.S. Pat. Pub. No. 2006/0039742, each incorporated by reference.
- AFDOCS/l 0666994.1 031528-01105 to one end of the ampoule by a pushing motion designed to force the ampoule to break under a compressive stress, sometimes at a predetermined area of stress concentration.
- a pressure may be applied to. a localized section of the ampoule through a squeezing motion designed to crush a section of the frangible ampoule in order to release the antimicrobial solution contained therein.
- Related art applicators often include a pledget provided in a fluid chamber to assist in controlling and/or direct the flow of solution from the solution container to the applicator head.
- the pledget may contain a dye.
- the solution passes through the pledget, the solution solubilizes the dye and becomes tinted.
- the solution then passes through the applicator head, to wet a foam, and is applied to a patient's skin.
- using a pledget to store the dye and tint the solution has several disadvantages.
- the pledget method may not provide consistency of tint intensity. Additionally, there is a possibility of the dye precipitating. With the pledget method, if the precipitation occurs immediately after the solution exits the
- AFDOCS/10666994.1 031528-01105 pledget clogging will occur in the fluid pathway.
- An example of an applicator with a pledget includes U.S. Pat. No. 7,182,536.
- an applicator assembly may include a head portion having a proximal end, a distal end, and an interior portion defining a fluid chamber; a container for containing an antiseptic solution coupled to and in fluid communication with the proximal end of the head portion; and an application member in fluid communication with the fluid chamber and comprising a foam, having a first foam layer adjacent a second foam layer, wherein the first foam layer is disposed toward the distal end of the head portion and comprises a dye impregnated therein, and the second foam layer is disposed away from the distal end of the head portion and is free from the dye, and wherein, after the antiseptic solution passes from the container through the fluid chamber, the antiseptic solution passes into the first foam layer, whereupon the dye is solubilized by and tints the antiseptic solution.
- FIG. 1 is a side cutaway view of a related art antiseptic applicator having a pledget
- FIG. 2 is a perspective view of an antiseptic applicator in accordance with certain aspects of the present invention.
- FIG. 3 is a perspective view of the head portion of the antiseptic applicator of FIG. 2.
- an antiseptic applicator may be illustrated by describing components that are coupled, attached, and/or joined together.
- the terms “coupled”, “attached”, and/or “joined” are used to indicate either a direct connection between two components or, where appropriate, an indirect connection to one another through intervening or intermediate components.
- a component is referred to as being “directly coupled”, “directly attached”, and/or “directly joined” to another component, there are no intervening elements present.
- Relative terms such as “lower” or “bottom” and “upper” or “top” may be used herein to describe one element's relationship to another element illustrated in the drawings. It will be understood that relative terms are intended to encompass different orientations of an antiseptic applicator in addition to the orientation depicted in the drawings. By way of example, if an antiseptic applicator in the drawings is turned over, elements described as being on the “bottom” side of the other elements would then be oriented on the “top” side of the other elements. The term “bottom” can therefore encompass both an orientation of “bottom” and “top” depending on the particular orientation of the apparatus.
- an antiseptic applicator may be illustrated with reference to one or more exemplary embodiments.
- the term "exemplary” means “serving as an example, instance, or illustration,” and should not necessarily be construed as preferred or advantageous over other embodiments of an antiseptic applicator disclosed herein.
- FIG. 1 shows an example related art antiseptic applicator 10.
- Antiseptic applicator 10 generally includes a body 12, and an application member 16 secured to flange of body 12 and a lever 26.
- a frangible ampoule 14 for containing antiseptic solution is received in body 12. One end is closed with cap 19.
- Body 12 includes an internal chamber 22.
- the wall of the applicator includes thinner wall 40. The thickness of the wall of body 12 is reduced around crush area 42. Thin wall 40 makes it easier for crush portion 36 of lever 26 to fracture ampoule 14 when lever 26 is depressed.
- Pledget 46 is positioned between application member 16 and ampoules 14. Pledget 46 helps control the rate liquid flows from the body and prevents shards of glass from
- Lever 26 includes hinge portion 38, crush portion 36 and handling portion 34 extending from the distal end of lever 26. When the lever 26 is depressed, force is transferred into the crush portion 36 of the lever 26.
- the pledget 46 is impregnated with a dye so that when antiseptic solution passes through the pledget, the dye is solubilized, thereby tinting the antiseptic solution.
- the foam application member 16 contains no dye and is comprised of a single uniform piece of foam.
- the antiseptic solution is released by actuating the lever 26 with enough force for the ampoule 14 to break. Additional structural and operational description of the applicator 10 may be found in U.S. Pat. No. 7,182,536, which is hereby incorporated by reference herein.
- FIGS. 2 and 3 show an example antiseptic applicator 100 in accordance with aspects of the present invention.
- the applicator 100 may comprise a substantially hollow container 102 containing or forming a fluid chamber, a head portion 110 coupled to a distal end of the container 102, and an application member 104 mounted to the head portion 110.
- the head portion 110 may include a proximal end, a distal end, and an interior portion defining a fluid chamber.
- a proximal end of the head portion 110 may be attached to the distal end of the container 102, while the distal end of the head portion 110 may be attached to the application member 104.
- the head portion 110 may be disposed between the container 102 and the application member 104.
- the applicator 100 may include an actuating arm 106, that, when depressed releases antiseptic solution stored in the container 102.
- actuating arm 106 that, when depressed releases antiseptic solution stored in the container 102.
- AFDOCS/l 0666994.1 031528-01105 solution from the container into the chamber of the head portion are included in the above-listed related art references, each of which is incorporated by reference herein. It should be understood that all of the structure shown in FIG. 2, besides the application member 104, may be substituted with any suitable structure found in the cited related art applicators. That is, one having ordinary skill in the art may apply the application member 104 to any known antiseptic applicator by replacing the application member of the related art antiseptic applicator with the application member 104. For example, the application member 104 may be applied to any of the application members of the above-cited references.
- a pledget similar to the pledget shown in FIG. 1 may also be included in the antiseptic applicator 100, but may not have dye impregnated therein. Thus, if a pledget is included it may serve the function of flow control, but may not serve the function of tinting the antiseptic solution.
- the application member 104 may comprise a foam sponge material, for example, or any suitable material that allows the controlled application of the contained solution from the container 102 to a surface external to the applicator 100.
- the foam may comprise polyurethane foam.
- the foam may hydrophilic or hydrophobic, depending on the antiseptic solution contained in the container. Suitable foams or other materials for the application member 104 may be found in the related applicators.
- the application member 104 may be impregnated with a dye.
- the application member 104 may include a first layer 1 12 and a second layer 1 14, wherein the first layer 1 12 is impregnated with the dye, while the second layer 1 14 is not impregnated with the dye.
- the first layer may be impregnated with dye by spray coating, dipping the foam into the
- the first foam layer 1 12 may be positioned or disposed toward the distal end of the head portion 1 10, and the second foam layer 1 14 may be disposed away from the distal end of the head portion 1 10.
- the foam layer having the impregnated dye may be the portion of the application member that is attached to the head portion, while the second foam layer without the dye may be the portion that contacts the patient's skin during use.
- the antiseptic solution first passes through the first foam layer having the dye and then passes through the second foam layer without the dye.
- the foam material chosen may be porous with a particular soak rate, for example, or may be provided with structural features, including slits or apertures, to direct and control the flow rate of the solution through the application member 104.
- the first and second foam layers may comprise the same or different foam materials. Additionally, the first and second foam layers may be integral with each other.
- the application member 104 may be formed from a single piece of foam wherein a first portion of the single foam is impregnated with dye while a second portion is free from the dye.
- the layers may be connected by a porous adhesive, sonic lamination, or heat lamination, for example.
- the container 102 is preferably a self-contained structure, formed of a suitable material, such as a plastic, e.g., a high-density polyethylene plastic, that is flexible, yet resistant to deformation and chemical leaching.
- a suitable material such as a plastic, e.g., a high-density polyethylene plastic, that is flexible, yet resistant to deformation and chemical leaching.
- the container 102 may be generally hollow so as to directly contain antiseptic solution or to contain an ampoule,
- the antiseptic solution releasing mechanisms of the related art applicators that allow the solution to flow from the container 102 into the chamber of the head portion may be implemented in the applicator of the instant invention. This may include devices that puncture an ampoule, tear a pouch, lift a plug, or otherwise provide a fluid pathway for antiseptic solution to flow into the chamber of the head portion.
- the antiseptic solution releasing mechanism includes actuating arm 106, which may be squeezed toward the fluid container 102 to puncture or break an ampoule having antiseptic solution contained therein.
- the applicator 100 may further include a filter layer disposed between the first and second foam layers that filters unsolubilized dye.
- This filter layer prevents unsolubilized dye from passing into the second layer which reduces clogging and provides a more uniformly tinted solution to pass into the second non-dyed foam layer and ultimately to the skin of a patient.
- the layer between the first and second foam layers may also be utilized to strengthen the connection between the first layer and the second layer.
- the filter layer comprises suitable pore size, pore density, and pore packing, relative to the dye sufficient to prevent unsolubilized dye from passing through the filter. It should be understood that the filter layer can be modified as necessary to possess a compatible pore size, density, and/or pore packing relative to the particular dye.
- raw foam material of the foam layers maybe modified depending on the particular dye.
- the applicator may also include a wicking layer disposed between the head portion and the first foam layer. The wicking layer allows for better distribution of antiseptic solution into the first foam layer by controlling the
- Wicking layers may be found in the related art applications, such as U.S. Patent No. 4,925,327, which is incorporated by reference herein.
- the dye impregnated within the first foam layer may be anionic or a cationic.
- the dye may be any dye suitable for medical use, such as dyes approved by the Food and Drug Administration for use in food, drugs, and/or cosmetics (i.e., "D&C” or "FD&C” dyes).
- the anionic dye may be employed within aqueous antiseptic solutions that include but are not limited to FD&C Blue No. 1 (Brilliant Blue FCF), FD&C Blue No.2 (Indigo Carmine), FD&C Green No.3 (Fast Green FCF), FD&C Red No.3(Erythrosine), FD&C Red No.
- an orange tint may comprise both FD&C Red No. 40 and D&C Yellow No.8.
- cationic dyes include crystal violet, acriflavine, Bismarck brown, malachite green, methyl green, Victoria pure blue BO, azure C, and combinations thereof.
- the antiseptic solution may comprise an antiseptic agent and a solvent, preferably an aqueous or an alcoholic solvent.
- the alcoholic solvent may be any alcohol-based solvent that is suitable for solubilizing antiseptic agent and dye.
- the solvent should also be suitable for medical use.
- Example alcoholic solvents include ethanol, isopropanol, n-propanol, and combinations thereof.
- the alcohol may be present in the solution from about 20 to about 90% v/v.
- the antiseptic agent may be any antiseptic that is suitable for medical use.
- the concentration of antiseptic in the antiseptic solution may vary depending on the specific antiseptic agent used, but may
- AFDOCS/10666994.1 031528-01105 generally range from about 0.00001 to 20% w/v.
- the preferred concentration may be about 0.0001 to about 0.5% w/v, more preferably about 0.01 to about 0.4% w/v, and more preferably about 0.1 to about 0.3% w/v.
- chlorhexidine or a chlorhexidine salt the preferred concentration may be from about 0.5 to about 6.0% w/v, more preferably from about 2.0 to about 4.0% w/v.
- the antiseptic agent may include biguanides.
- Example biguanides include chlorhexidine free base, chlorhexidine diphosphanilate, chlorhexidine digluconate, chlorhexidine diacetate, chlorhexidine dihydrochloride, chlorhexidine dichloride, chlorhexidine dihydroiodide, chlorhexidine diperchlorate, chlorhexidine dinitrate, chlorhexidine sulfate, chlorhexidine sulfite, chlorhexidine thiosulfate, chlorhexidine di - acid phosphate, chlorhexidine difluorophosphate, chlorhexidine diformate, chlorhexidine dipropionate, chlorhexidine diiodobutyrate, chlorhexidine di-n-valerate, chlorhexidine, dicaproate, chlorhexidine malonate, chlorhexidine succinate, chlorhexidine malate, chlorhexidine tartrate, chlorhexidine dimonoglycolate, chlorhexidine
- the antiseptic agent may include quaternary ammonium compounds.
- Example quatemary ammonium compounds include benzalkonium chloride (BZK), benzethonium chloride, other benzalkonium or benzethonium halides, cetylpyridiniumchloride, dequaliniumchloride, N-myristyl-
- Nmethylmorpholiniummethylsulfate poly[N-[3-(dimethylammonio)propyl]-N'-[3- (ethyleneoxyethelenedimethylammonio)propyl]urea dichloride], alpha-4-[1 -tris(2- hydroxyethyl)ammoniumchloride-2-butenyl]-omegatris(2-hydroxyethyl)ammonium chloride, alpha4-[1 -tris(2-hydroxyethyl)ammoniumchloride-2-butenyl]poly[1 - dimethylammoniumchloride-2-butenyl]-omegatris(2hydroxyethyl)ammoniumchloride, poly[oxyethylene(dimethyliminio)ethylene(dimethyliminio)-ethylenedichloride], ethylhexadecyldimethylammoniumethylsulfate, dimethylammoniumethylsulfate, dimethylethyl-benzy
- the antiseptic agent may include chlorinated phenol compounds.
- Example chlorinated phenol compounds may include parachlorometaxylenol, triclosan (2,4,4 - trichloro-2 hydroxy di-phenyl ether), 2-chlorophenol, 3-chlorophenol,4-chlorophenol, 2,4-dichlorophenol, 2,4,6-trichlorophenol, 2,3,4,6-tetrachlorophenol, pentachlorophenol,4-chlororesorcinol, 4,6-dichlororesorcinol, 2,4,6-trichlororesorcinol, alkylchlorophenols (including p-alkylo-chlorophenols, o-alky 1 -p-chlorophenols, dialkyl- 4-chlorophenol, and tri-alkyl-4-chlorophenol), dichloro-m- xylenol, chlorocresol, o-
- AFDOCS/10666994.1 031528-01105 benzyl-p-chlorophenol, 3,4,6-trichlorphenol, 4-chloro-2-phenylphenol, 6-chloro-2- phenylphenol, o-benzyl-p-chlorophenol, and 2,4-dichloro-3,5-diethylphenol.
- antiseptic agents include triclosan, octenidine salts, pyridinium and isoquinolinium compounds, amidine derivatives such as hexamidine isethionate (4,4'-diamidinoa,w-diphenoxyhexane isethionate), and bispyridine derivatives such as octenidine(N,WC1 ,10-decanediyldi-1 (4H)-pyridinyl-4-ylidene]-bis(1 - octanaminedihydrochloride).
- amidine derivatives such as hexamidine isethionate (4,4'-diamidinoa,w-diphenoxyhexane isethionate
- bispyridine derivatives such as octenidine(N,WC1 ,10-decanediyldi-1 (4H)-pyridinyl-4-ylidene]-bis(1 - octanaminedihydrochloride).
- Example pyridinium and isoquinolinium compounds include hexadecylpyridinium chloride, cetylpyridinium chloride and alkyl isoquinolinium bromidepyrimidine derivatives such as hexetidine (5-amino-1 ,3-bis(2-ethylhexyl)-5- methylhexahydropyrimidine).
- Preferred examples of antiseptic agents include chlorhexidine salts, octenidine salts, alexidine, halophenols, phenoxyethanol, benalkonium chloride, parachlorometaxyelanol (PCMX), and combinations thereof.
- the antiseptic solution may include a solubilization aid.
- Example solubilization aids include polyethylene glycol (PEG) average molecular weight 200, PEG average molecular weight 300, PEG average molecular weight 400, and glycerol.
- the concentration of solubilization aid in an aqueous antiseptic solution may be from about 1 to about 49% v/v.
- the antiseptic solution is storied in an ampoule (not shown) within the container 102.
- the operator engages the antiseptic solution releasing mechanism.
- the operator applies pressure to the actuation arm 106 toward the container 102.
- Actuation of the antiseptic solution releasing mechanism opens a fluid pathway for the antiseptic solution to travel from the container into the chamber of the head portion 110.
- actuation of the actuation arm 106 breaks the ampoule containing the antiseptic solution. Once broken, the antiseptic solution is free to flow into the container 102 and then into the chamber of the head portion 110.
- a pledget that is preferably free from dye may be present within the flow path to control the flow into the antiseptic solution into the chamber of the head portion.
- the solution passes into the application member 104.
- the solution first passes into the first foam layer 112 of the application member 104, because the first foam layer 112 is connected to the head portion 110.
- the solution is preferably distributed throughout the layer and solubilizes dye that is impregnated within the first foam layer.
- the antiseptic solution becomes tinted as a result of solubilizing the dye.
- the tinted antiseptic solution then continues to flow into the second layer 114, which does not contain dye.
- the tinted antiseptic solution is preferably distributed throughout second foam layer, thus further controlling the flow of antiseptic
- the second foam layer serves similar flow control and distribution function as the foam in the related art application members.
- the solution may also pass through a wicking layer disposed between the head portion 1 10 and the first foam layer 1 12, and/or may pas through a filter layer disposed between the first foam layer 1 12 and the second foam layer 1 14.
- the tinted antiseptic solution passes from the second foam layer 1 14 onto the skin of the patient. Because the solution is tinted, the operator has a visual indication of which portions of the skin are covered with antiseptic solution.
Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
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CN201480005763.3A CN104955585B (en) | 2013-01-23 | 2014-01-15 | Preservative application member |
AU2014209740A AU2014209740B2 (en) | 2013-01-23 | 2014-01-15 | Antiseptic applicator |
ES14743815T ES2937664T3 (en) | 2013-01-23 | 2014-01-15 | antiseptic applicator |
CA2899164A CA2899164C (en) | 2013-01-23 | 2014-01-15 | Antiseptic applicator |
EP14743815.4A EP2948256B1 (en) | 2013-01-23 | 2014-01-15 | Antiseptic applicator |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US13/748,123 US9119946B2 (en) | 2013-01-23 | 2013-01-23 | Antiseptic applicator |
US13/748,123 | 2013-01-23 |
Publications (1)
Publication Number | Publication Date |
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WO2014116482A1 true WO2014116482A1 (en) | 2014-07-31 |
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PCT/US2014/011650 WO2014116482A1 (en) | 2013-01-23 | 2014-01-15 | Antiseptic applicator |
Country Status (7)
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US (1) | US9119946B2 (en) |
EP (1) | EP2948256B1 (en) |
CN (1) | CN104955585B (en) |
AU (1) | AU2014209740B2 (en) |
CA (1) | CA2899164C (en) |
ES (1) | ES2937664T3 (en) |
WO (1) | WO2014116482A1 (en) |
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USD815439S1 (en) | 2015-03-06 | 2018-04-17 | The Libman Company | Soap dispenser |
USD777447S1 (en) | 2015-03-06 | 2017-01-31 | The Libman Company | Soap dispenser |
DE102015122263A1 (en) * | 2015-12-18 | 2017-06-22 | Schülke & Mayr GmbH | Alcoholic disinfectant for the control of viruses |
CN105536128A (en) * | 2016-01-18 | 2016-05-04 | 常州市第四制药厂有限公司 | Applying and smearing device for administration of auxiliary semi-solid preparation and liquid preparation |
US10689152B2 (en) | 2016-08-22 | 2020-06-23 | James Alexander Corporation | Dispenser and process |
US11247837B1 (en) | 2017-08-21 | 2022-02-15 | James Alexander Corporation | Dispenser actuator assembly |
US11241709B1 (en) | 2018-10-11 | 2022-02-08 | James Alexander Corporation | Dispenser actuator assembly |
US11542136B1 (en) | 2018-10-11 | 2023-01-03 | James Alexander Corporation | Dispenser actuator assembly |
US11857747B1 (en) | 2018-10-11 | 2024-01-02 | James Alexander Corporation | Dispenser actuator assembly |
US11920039B2 (en) * | 2019-01-30 | 2024-03-05 | Battelle Savannah River Alliance, Llc | Malachite green based radio-chromic compounds and radiation sensing systems incorporating the compounds |
WO2023119122A1 (en) * | 2021-12-20 | 2023-06-29 | 3M Innovative Properties Company | Applicator and method of making same |
US20230321416A1 (en) * | 2022-04-06 | 2023-10-12 | Carefusion 2200, Inc. | Applicator for coloring antiseptic |
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- 2014-01-15 EP EP14743815.4A patent/EP2948256B1/en active Active
- 2014-01-15 WO PCT/US2014/011650 patent/WO2014116482A1/en active Application Filing
- 2014-01-15 CN CN201480005763.3A patent/CN104955585B/en active Active
- 2014-01-15 AU AU2014209740A patent/AU2014209740B2/en active Active
- 2014-01-15 ES ES14743815T patent/ES2937664T3/en active Active
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Also Published As
Publication number | Publication date |
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US20140205360A1 (en) | 2014-07-24 |
AU2014209740A1 (en) | 2015-08-06 |
CA2899164A1 (en) | 2014-07-31 |
CN104955585A (en) | 2015-09-30 |
US9119946B2 (en) | 2015-09-01 |
CA2899164C (en) | 2020-08-18 |
EP2948256A4 (en) | 2016-10-26 |
EP2948256A1 (en) | 2015-12-02 |
ES2937664T3 (en) | 2023-03-30 |
AU2014209740B2 (en) | 2018-06-07 |
EP2948256B1 (en) | 2022-12-14 |
CN104955585B (en) | 2018-04-13 |
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